FDA 510(k) Application Details - K180313

Device Classification Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder

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510(K) Number K180313
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Mag & More GmbH
Machtlfinger Strasse l3
Munich 81379 DE
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Contact Kerstin Haringer
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 02/05/2018
Decision Date 05/04/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K180313


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